Growing trend for investments, number of centers and trials. We talked about it with Francesco De Santis, Vice President of Farmindustria for research and President of Italfarmaco.
Since the 'Bindi Decrees' of 1998, clinical research in Italy, freed from the regulatory and administrative brakes that slowed it down, has been able to speed up catching up with other countries, European and beyond. Today the quality of the centres, the medical class, the personnel of the industry and of the service companies on the subject make our country potentially one of the most suitable for carrying out clinical trials. To increase the investments of Italian companies and to attract the capital of multinationals, in their 'internal market1 of investment destination. This is demonstrated by the positive growth trend of the last three years. We talked about all this and, more generally, about the industry's position on clinical research with Francesco De Santis, Vice President of Farmindustria with responsibility for research and President of Italfarmaco. Dr. De Santis, what is the position of pharmaceutical companies on clinical research? How do you evaluate the current trend of clinical research in Italy and what, in your opinion, will be the development that will distinguish it in the coming years? F. De Santis – "Clinical research constitutes the main investment in research for the pharmaceutical industry, equal to approximately 70% of what we spend to discover and develop new drugs to bring to the community. In 2006 the resources invested for clinical studies and trials have grown by 12% compared to the previous year, a three-year growth trend testifying to the willingness and conviction of companies to generate innovation.Experimentation costs are increasing, but so is the number of experimentations taking place in Italy, as are the centers where they are carried out, as evidenced by the data from the latest edition of the Observatory on Clinical Trials of AIFA a few weeks ago. It is significant how the number of clinical centers compliant with European, actually global, regulations that preside over clinical research are growing". What are the main characteristics, including critical issues and opportunities, related to the role of Italian companies and multinationals operating in Italy in the field of clinical research. F. De Santis – "One of the positively distinctive features in our country is the presence of networks of research centres, for example in the oncology or cardiovascular fields. These are realities which in many respects facilitate the activation and conduct of trials, as the number of centers 'compliant' with international rules is increasing, even in the face of an averagely high professional quality of the medical profession". And the critical issues? • • . – ' F. De Santis – "The critical issues come from the excessive presence of bureaucratic slowness and from administrative processes without added value. We often find ourselves having to work with clinical centers of high medical quality in which, however, the experimentation does not start for reasons purely bureaucratic or starts late, i.e. when enrollment in other centers abroad is already advanced, therefore often cutting our excellent clinicians out of the international project.Also because enrollment is now competitive, and who can enroll more does until the statistical sample planned for that study is reached". Ethics committees… F. De Santis – "Italy has made great strides on ethics committees, particularly in the
